Job Information
Amneal Pharmaceuticals LLC (J0P) Supervisor, Manufacturing Technical Services in Piscataway, New Jersey
Description:
This position will lead the execution of new product launches from initiation to completion.Manage process and cleaning validation studies for various formulations to include transdermal, topical, medical devices, solutions and suspensions. Process changes to support existing products and optimization of existing products/processes. This role is responsible for understanding the company's and customers' technical needs; and developing, defining, and implementing short and long-term technical service strategies to achieve company and customer needs. Manage project timelines, deliverables to ensure successful completion of validation projects within scope. Schedule and coordinate with cross-functional teams to align validation, post approval projects activities with project objectives and regulatory requirements.
Essential Functions:
Prepare, review and executevalidation documents for Transdermal and Topical products.
Identify opportunities to improve documentation practices and compliance Manage product launches, manufacturing technology transfers to validation and manufacturing groups, process improvement.
Manage product launches, manufacturing technology transfers to validation and manufacturing groups, process improvement.
Transfer the technical knowledge of the process (by working with the project scientist) to manufacturing.
Participate in the deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA).
Provide life cycle management support to all existing products and processes, and enable execution of continuous improvement programs.
Review batch production records and identify opportunities to improve documentation practices and compliance.
Provide periodic updates to senior management on progress of projects, risk and mitigation plan.
Ensure staff is adequately trained to perform job assignments. May identify and develop specific training content to support ongoing development efforts, supervise and/or mentor junior level engineers.
Additional Responsibilities:
Prepareand review Manufacturing and packagingbatch records,initiate Change Controls and Planned/Unplanned Deviations.
ReviewAnnual Product Reviews.
Understands new technology platforms and drug developments.
Conduct statistical analysis.
Education:
Bachelors Degree (BA/BS) Degree in Science, Engineering, Manufacturing Technology or closely related field - Required
Master Degree (MS/MA) Degree in Science, Engineering, Manufacturing Technology or closely related field - Preferred
Experience:
4 years or more in Pharmaceuticals/ Chemical with BS
Skills:
Oral and written communication skills with the ability to speak and write with clarity and structure. - Advanced
Ability to interpret and prepare technical reports/documents with clarity and ease of presentation. - Advanced
Proficient skills level using Microsoft applications, including Word, Excel & PowerPoint. - Advanced
Good subject knowledge and problem solving skills required. - Advanced
Specialized Knowledge:
FDA's validation guidelines & requirements.
Demonstrated knowledge and understanding of oral dosage formulation process, manufacturing process and equipment.
21 CFR
Statistical analysis.
Thorough knowledge of cGMP guidelines, GLP Practices and regulatory guidelines.
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity